Johns Hopkins Safety Manual
Guidance Number
Subject:
Review Date
Guidance for Employees Using Ortho-phthalaldehyde
(Cidex® OPA) to Disinfect Equipment
Page
To:
HSE G03
09/20/13
1 of 9
Employees who perform high level disinfection on medical equipment and/or work in the area where
Ortho-phthalaldehyde (Cidex® OPA) is used
Rationale:
Ortho-phthalaldehyde (Cidex® OPA) is a chemical which must be used according to manufacturer’s directions in
order to protect employees, visitors and patients.
Ortho-phthalaldehyde must not be used on medical equipment unless the manufacturer (not the distributor)
recommends that it be used on this specific piece of equipment.
If you do so without the manufacturer recommendation, you may void the warranty on this equipment.
References:
29 CFR 1910.1030 Blood Borne Pathogen
29 CFR 1910.1200 Chemical Right to Know
29 CFR 1910 subpart K section (29 CFR 1910.151 (c) medical services and first aid.
ANSI/AIHA Z9.5-1992, 5.8
Baltimore Code Article 25 Sewers § 2-5 (h) Limitations on Discharges into Sanitary Sewers & § 6-5 Program to
Reduce Volume and Toxicity.
Department of the Environment (COMAR 16.13.02) Identification and Listing of Hazardous Waste.
Department of the Environment (COMAR 26.13.03) Standards Applicable to the Generators of Hazardous Waste.
FDA Notice dated 10/31/07 “Public Health Notification from FDA, CDC, EPA and OSHA: Avoiding Hazards
Using Cleaners and Disinfectants on Electronic Medical Equipment.
HSE policy # 004 Incident and Injury Reporting
HSE policy # 005 Occupational Injury Management
HSE policy # 501 Blood Borne Pathogen Annual Exposure Plan
HSE policy # 703 Management of Hazardous Chemicals
Miller, Kristine M., MFA. (Ed) Protecting Those Who Serve: Health Care Worker Safety. Oakbrook Terrace: Joint
Commission Resources, Inc, 2005
NFPA 45, Chapter 6-8.7.1
1.
Any site which decides to use Ortho-phthalaldehyde needs to report this to Hospital Epidemiology and
Infection control (Ext. 5-8384) AND Health, Safety and Environment (Ext. 5-5918).
2.
The current logs (eyewash log, Johns Hopkins Hospital Cidex® OPA Daily Log and the Johns Hopkins Cidex®
OPA Strips Weekly QA Log must be kept on a clipboard near the location where the Ortho-phthalaldehyde is
being used.
3.
Reference material (listed in Appendix A) and all previous logs (eyewash log, Johns Hopkins Cidex® OPA
Daily Log, and Johns Hopkins Cidex® OPA Strips Weekly QA Log) must be kept in a notebook in a location
readily available to the employees working with the Ortho-phthalaldehyde. This will be referred to as the
Cidex® OPA Reference Book.
4.
Rooms where Ortho-phthalaldehyde is in use must have ten (10) air exchanges per hour OR a chemical fume
hood OR local exhaust approved by HSE.
A. For disinfecting equipment in containers with small mouth diameter openings (4 inches or less in diameter)
contact HSE for permission. (Ext. 5-5918).
Johns Hopkins Safety Manual
Guidance Number
Subject:
Review Date
Guidance for Employees Using Ortho-phthalaldehyde
(Cidex® OPA) to Disinfect Equipment
Page
5.
HSE G03
09/20/13
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A visual indicator must be used to assess proper fume hood operation. The assessment of the visual indicator
will be documented on the Johns Hopkins Hospital Cidex® OPA Daily Log
A. The Visual Indicator is a yellow ribbon attached to a sign with appropriate contact phone numbers for
assistance with a chemical fume hood.
B. The Visual Indicator is attached to the front of the chemical fume hood.
C. If the yellow ribbon is moving in towards the hood exhaust, this indicates that the hood is working.
D. If the yellow ribbon is motionless or barely working this indicates that the hood is probably not working.
1.
The purpose of the chemical fume hood is to protect employees, visitors and patients from exposure to
the fumes of Ortho-phthalaldehyde.
2.
If the hood is not working it is important to have it fixed immediately in order to avoid exposure to
fumes.
3.
Call in the request to Facilities (Ext. 5-5770) for immediate assessment. The Community Sites will be
using other companies or contacts. Appendix D will be used to identify these sites for specific
locations
6.
The container used to soak the equipment in Ortho-phthalaldehyde (Cidex® OPA) must be covered at all times
except when the employee is manipulating the equipment or working with the solution (testing, neutralizing or
disposing of the Ortho-phthalaldehyde),
7.
Rooms with at least ten air exchanges where Cidex® OPA is in use and where no chemical fume hood or local
exhaust is in use must keep their doors closed to facilitate the correct number of air exchanges.
8.
Rooms with at least ten (10) air exchanges where Cidex® OPA is in use and where no chemical fume hood is
in use, must have the air exchanges for this room assessed yearly.
9.
Sites using a chemical fume hood must have the hood certified annually. This means that the certification must
occur by the final day of the month in which the certification is due.
10. Rooms where Ortho-phthalaldehyde is in use must be clearly marked (on door or next to entrance if door is
usually open) with a yellow caution sign. (See caution signs requirements in HSE # 501 Blood Borne Pathogen
Exposure Control Plan.)
A. Blood Borne Pathogen Symbol
B. No food or drink label
C. Protective clothing required
D. Ortho-phthalaldehyde (Cidex® OPA) in use
E. Contact information
1. For High Level Disinfection, questions contact HEIC at Ext. 5-8384.
2. For Safety questions contact HSE at Ext. 5-5918.
3. Name of site persons from this site to be contacted in an emergency.
11. Containers which are used for Ortho-phthalaldehyde must be clearly marked with the complete name (generic
or brand name) and the dates the solution was poured into the container and the date (fourteen (14) days later)
that the solution is to be discarded.
12. In order to safely use Ortho-phthalaldehyde, employees need to:
13. A. Be Trained:
1.
Be trained on its use either by HEIC, HSE, a Nurse Educator or on-line training annually.
2.
The Manufacturer’s representative will know the correct process for use of Cidex® OPA but will not
know training which is specific to our institution. IF the manufacturer’s representative is used to
provide training, someone from HEIC or HSE or a Nurse Educator will have to provide the site
specific training
Johns Hopkins Safety Manual
Guidance Number
Subject:
Review Date
Guidance for Employees Using Ortho-phthalaldehyde
(Cidex® OPA) to Disinfect Equipment
Page
HSE G03
09/20/13
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a.
The on-lining training has a twenty-five (25) question test that all employees using Orthophthalaldehyde must take and pass annually.
b.
The computer actually contains forty (40) test questions. The computer randomly chooses twentyfive (25) of the forty questions for each employee to answer.
c.
Instructors must administer a version of this test any time they provide in person training.
3.
Training logs for instructor led courses must be submitted to HSE. (See Appendix B) when a Nurse
Educator, HEIC employee, or an HSE employee is doing the training. It will then be entered in the
My Learning list of completed courses for that employee.
4.
Training is currently available on Health Stream and on My Learning web site
http://www.hopkinsmedicine.org/hse/training/
5.
The Nurse Educator in your department can arrange for you to have access to the Health Stream
course.
6.
If you have problems accessing the training, you can contact HSE at 5-5918 to arrange for access to
the Ortho-phthalaldehyde training on My Learning.
7.
Annually training means that the training has been taken at the latest by the thirteen (13) month
anniversary of previous training.
8.
A copy of the most recent proof of Cidex® OPA training must be kept in the Cidex® OPA Reference
Book.
B. Follow the manufacturer’s directions when using Ortho-phthalaldehyde in order to protect
themselves, other employees, visitors and patients from adverse events related to the use of Orthophthalaldehyde.
C. Follow the directions of the manufacturer of the medical device being disinfected.
D. Instrument must be cleaned prior to being put into high level disinfectant
1.
When the instrument is cleaned, it must be rinsed in order to remove the enzymatic detergent.
2.
The instrument must be dried prior to inserting it into the ortho-phthalaldehyde.
3.
If this is not done, you will dilute the ortho-phthalaldehyde with the rinse water (or the
enzymatic detergent if you failed to rinse the instrument).
E. Be aware that Ortho-phthalaldehyde will stain organic material – such as skin, clothing and counters made
with organic materials -- a grey color.
F.
IF you remove the instrument from the ortho-phthalaldehyde and you notice a grey color on the instrument,
you must start the whole disinfection process over.
1.
The grey color indicates that organic material was on the instrument when it went into the orthophthalaldehyde.
2.
This means the cleaning process was not done properly.
G. Appropriate PPE must be worn
1.
Nitrile gloves.
2.
Eye/face protection (face shield # 32972 or “goggles, chem. Splash” #20580) and
3.
Fluid impermeable gowns.
H. Follow the manufacturer’s directions for determining the Minimum Effective Concentration (MEC) of
Ortho-phthalaldehyde (Cidex® OPA) before each use of the solution by using Cidex® OPA Test Strips.
Johns Hopkins Safety Manual
Guidance Number
Subject:
Review Date
Guidance for Employees Using Ortho-phthalaldehyde
(Cidex® OPA) to Disinfect Equipment
Page
HSE G03
09/20/13
4 of 9
Record results on log.
I.
J.
When you check the MEC, you must also assess the temperature of the Ortho-phthalaldehyde (Cidex®
OPA) and record it on the log.
1.
Contact time – as it relates to a disinfectant – is the length of time that the disinfectant must remain wet
on the clean surface of the instrument being disinfected in order to kill the organisms on that surface.
It must also be inserted into any instrument lumens for the same length of time.
2.
The contact time of twelve (12) minutes for Ortho-phthalaldehyde is good ONLY if the solution is at
least 20° C (= 68° F).
3.
If the temperature is below 20° C., disinfection is not adequate and the equipment cannot be used.
4.
DPP400W Cooper Waterproof Digital Thermometer (Cooper Atkins) is recommended for measuring
the temperature. SAP # 122097
Perform QA on Cidex® OPA Test Strips
1. Cidex® OPA Test Strips are to be QA tested at the time the bottle of strips is opened for the first time,
per manufacturer’s directions.
a. If a new bottle of test strips fails the QA test and a second new bottle with the same lot number
also fails the QA test, save both bottles and packaging for investigation. The entire lot may be
defective.
b. Contact Clinical Products Specialist (x-2-1900) to report when two (2) or more new bottles of
Cidex® OPA Test Strips with the same lot number fail QA testing. Document this information in
the Remarks column and continue documentation on back of the current log if there is insufficient
space on the front.. (date/time/name/lot #/etc.)
2. The strips should be QA tested weekly.
3. If you need fresh Ortho-phthalaldehyde (Cidex® OPA) to perform the QA on the Cidex® OPA strips
the following week, leave enough Ortho-phthalaldehyde in the original manufacturer’s container to
perform the test.
a. Tightly cap the original manufacturer’s container of Ortho-phthalaldehyde (Cidex® OPA).
b. Date the original manufacturer’s container to expire in seventy-five (75) days from the date
opened.
c. If the manufacturer’s expiration date is less than seventy-five days from the date the bottle was
opened, then you use the manufacturer’s expiration date.
d. This is considered to be fresh Ortho-phthalaldehyde (Cidex® OPA) if these rules are followed.
4. Expiration dates:
a. Both Cidex® OPA and Cidex® OPA strips have manufacturer’s expiration dates.
b. Both have new expiration dates based on the date the container was opened.
c. The Rule: The earliest expiration date is the one you use when you have two expiration dates.
K. Triple rinse the manufacturer’s original container with water and then dispose of container in regular trash.
L. Lumens of medical equipment must be manually irrigated with detergent solution, Ortho-phthalaldehyde
and rinse solutions.
1. When the syringe is filled with the solution, it must be carefully filled and securely attached to the
channel opening or channel irrigator.
2. The solution must be slowly pushed into the channel.
3. If too much force is used, the syringe will separate from the channel and spray the employee.
a. If this happens and the solution touches the employee’s mouth and/or eye(s), follow HSE Policies
# 004 and 005. This should not happen if you are wearing the appropriate PPE.
b. Employee must be able to report what they were exposed to: (See Appendix C for Risk
Assessment of Exposure to Chemicals and Blood Borne Pathogens.)
i. Unused enzymatic detergent/water solution
ii. Used enzymatic detergent/water solution
iii. Rinse water after use of enzymatic detergent
Johns Hopkins Safety Manual
Guidance Number
Subject:
Review Date
Guidance for Employees Using Ortho-phthalaldehyde
(Cidex® OPA) to Disinfect Equipment
Page
HSE G03
09/20/13
5 of 9
iv. Ortho-phthalaldehyde solution or
v. Type of Rinse Solution and whether it is the 1st, 2nd, or 3rd rinse.
M. Neutralize all Ortho-phthalaldehyde following the directions for the Glycine. This includes any Orthophthalaldehyde which has expired while in the manufacturer’s original container.
a. The neutralization must be documented on the Johns Hopkins Hospital Cidex® OPA Daily Log
b. One ounce of Glycine per 1 gallon of Ortho-phthalaldehyde.
c. Mix the Glycine and the Ortho-phthalaldehyde thoroughly.
d. Let the mixture set for one hour.
e. Neutralized Ortho-phthalaldehyde can be flushed down the sink with copious amounts of water.
2. Glycine is available free of charge from HSE (Ext. 5-5918).
3. Unused Glycine should be returned to HSE.
4. HSE uses the amount of Glycine distributed to estimate the amount of ortho-phthalaldehyde being
neutralized for EPA reporting.
14. Spills of Cidex® OPA will be cleaned up utilizing the “Guidelines for Spill Clean-UP of Cidex® OPA
Solution” from Advanced Sterilization Products®.
15. Automatic Endoscope Reprocessors:
A. The Automatic Endoscope Reprocessor must be capable of being set to at least 25° C (=77° F) if is being
used with Cidex OPA.
B. It is not possible to neutralize the Ortho-phthalaldehyde used in automatic Endoscope Reprocessors.
Johns Hopkins Safety Manual
Guidance Number
Subject:
Review Date
Guidance for Employees Using Ortho-phthalaldehyde
(Cidex® OPA) to Disinfect Equipment
Page
HSE G03
09/20/13
6 of 9
Appendix A: These most recent references are available on the HSE web site via a link “Forms” immediately
below the link for this Guidance Document.
Additional References for this Guideline – which must be available to employee working with Cidex® OPA:
1.
Manufacturer’s directions for the following are required for safe use of Cidex ® OPA:
A. Directions for Cidex® OPA
B. Directions for Cidex® OPA Solution Test Strips
C. Directions for Glycine (See label of jar)
D. Directions for the equipment being disinfected
E. Directions for the enzymatic detergent being used to clean the equipment
F. Advanced Sterilization Products® chart entitled “How to Use Cidex® OPA Solution”
G. Why you should test your Cidex® OPA
H. Cidex® OPA technical information
I. “Guidelines for Spill Clean-Up of Cidex® OPA Solution”
J. Directions for the use of the Automatic Endoscope Reprocessor – IF you are using one.
2.
MSDS sheets for the following:
A. Cidex® OPA
B. Glycine
C. The enzymatic detergent being used to clean the equipment. Johns Hopkins currently has two authorized
enzymatic detergents: Enzol® and Asepti®-zyme.
D. Cidex® OPA Strips – Non MSDS letter
3.
Policies (Only the policy/policies pertinent to the equipment/procedures in use in your location.)
A. IFC Policy # 014: Cleaning & Disinfection with Appendices
B. Nursing policies for Endoscopy
C. HSE Policy # 037: Emergency Equipment: Eye Wash, Drenching Hose and Shower Equipment
4. FDA notice dated 10/31/07 “Public Health Notification from FDA, CDC, EPA and OSHA: Avoiding Hazards
Using Cleaners & Disinfectants on Electronic Medical Equipment. Some of the links in this document are no longer
useable but the material in the document is still up-to-date.
1. Some of the equipment being disinfected with Ortho-phthalaldehyde at JH is electrical equipment.
2. This notice contains other information of interest to anyone working with Ortho-phthalaldehyde.
Johns Hopkins Safety Manual
Guidance Number
Subject:
Review Date
Guidance for Employees Using Ortho-phthalaldehyde
(Cidex® OPA) to Disinfect Equipment
Page
HSE G03
09/20/13
7 of 9
CIDEX® OPA TRAINING LOG
Instructor
Course Number
Location
Campus
H16
Building
Date
From
To
Information Covered
-
MSDS Sheets for Cidex® OPA, enzymatic detergent, Glycine
Policies on Disinfection & Cleaning & Cidex® OPA
Directions for equipment being disinfected, Cidex® OPA, Cidex® OPA strips
Engineering Controls (Ventilation [room, local and fume hood])
Administrative Controls (Policy (+logs)
Work Practice Controls (PPE)
Eyewash requirements will be covered in local eyewash training
Cleaning Process
Disinfection Process
Neutralization of Cidex® OPA
QA on Cidex® OPA Strips
Clinical Precautions
Other
Summary Of Demonstrations
- Demonstration of QA on Cidex® OPA Strips
Attendance
Name
Signature of Person providing training:
Badge or JHED Number
Signature
Date:
Title of person providing training
Training Records
Revised: 9/18/09
Fax a copy to the Health, Safety and Environment office at 5-5929
Johns Hopkins Safety Manual
Guidance Number
Subject:
Review Date
Guidance for Employees Using Ortho-phthalaldehyde
(Cidex® OPA) to Disinfect Equipment
Page
HSE G03
09/20/13
8 of 9
Appendix C:
Risk Assessment of Exposure to
Chemicals & Blood Borne Pathogens
EXPOSED TO
RISK OF CHEMICAL
EXPOSURE
RISK OF BLOOD BORNE
PATHOGEN EXPOSURE
Enzomatic Detergent
(Enzol® or Asepti-zyme®) +
water
Medium
High
Rinse after use of Enzymatic
detergent
Low
High
Ortho-phthalaldehyde
(Cidex® OPA)
High
Varies on how long the
instrument has been in the
solution
Rinse #1
High
Low
Rinse #2
Medium
Low
Rinse #3
Low
Low
Appendix D
Community Locations
Green Spring Station & White Marsh
Odenton
Contact Person
Timothy Rose
Company & Phone Number
JH Facilities – 410-955-6063